Protocol: Phytomedicine-AMARGOL®, Clinical Trial for Efficacy Proof on Therapeutics

This study has been completed.
Sponsor:
Collaborator:
Phytopharm Consulting Brazil
Information provided by (Responsible Party):
Laboratorio Saude Ltda.
ClinicalTrials.gov Identifier:
NCT01485328
First received: December 16, 2008
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic digestive complaints.


Condition Intervention Phase
Digestive System Disorders
Drug: AMARGOL®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics

Resource links provided by NLM:


Further study details as provided by Laboratorio Saude Ltda.:

Primary Outcome Measures:
  • VAS - visual analogue scale [ Time Frame: 24h ] [ Designated as safety issue: No ]
    Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal


Enrollment: 60
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMARGOL
per oral solution 40 mL single dose
Drug: AMARGOL®
per oral solution, 40 mL single dose
Other Names:
  • AMARGOL
  • Phytomedicine
  • Herbal Extracts Mixture
Placebo Comparator: Vehicle without active principles
per oral solution 40 mL single dose
Drug: AMARGOL®
per oral solution, 40 mL single dose
Other Names:
  • AMARGOL
  • Phytomedicine
  • Herbal Extracts Mixture

Detailed Description:

This study will be performed for proving the efficacy of AMARGOL®, a phytomedicine product, under the Brazilian law for registration and revalidation RDC 14/2010.

AMARGOL® indications are for non specific digestive complaints as laxative and anti-dyspeptic.

Is a mixture of 7 plant extracts: Aloe ferox, Angelica archangelica, Alpinia officinarum, Cinnamomum zeylanicum, Gentiana lutea, Commiphora myrrh and Rheum palmatum.

Placebo controlled test

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-45 years old
  • 65-85 Kg
  • healthy volunteers

Exclusion Criteria:

  • chronic dyspeptics illness chronic congestive cardiac problems
  • pulmonary problems
  • diabetes, thyroid problems
  • pregnancy
  • bowel syndrome
  • hemorrhoids
  • colitis
  • allergies for any formula components.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485328

Locations
Brazil
Phytopharm Consulting
Porto Alegre, RS, Brazil, 90130-021
Sponsors and Collaborators
Laboratorio Saude Ltda.
Phytopharm Consulting Brazil
Investigators
Principal Investigator: Angelo G Chaves, Doctor
  More Information

No publications provided

Responsible Party: Laboratorio Saude Ltda.
ClinicalTrials.gov Identifier: NCT01485328     History of Changes
Other Study ID Numbers: labsaude-001-ama
Study First Received: December 16, 2008
Last Updated: December 5, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Laboratorio Saude Ltda.:
Dyspepsia
Flatulence
Aerophagia
Constipation

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 01, 2014